Galectin Therapeutics Inc. · NASDAQ:GALT
Galectin Therapeutics — Investor Presentation (February 2014)
33 slides from Galectin Therapeutics's investor presentation, Feb 10, 2014
Slide 1: Corporate Presentation
EXHIBIT 99.1 Corporate Presentation February 10, 2014 NASDAQ: GALT © 2014 Galectin Therapeutics www.galectintherapeutics.com NASDAQ:GALT
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains, in addition to historical information, statements that look forward in time or that express management’s beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Refor
Slide 3: Agenda
Agenda • The Company and Key Team Members • Galectin Inhibitors • Fibrosis Program – our primary focus • Cancer Immunotherapy • Summary © 2014 Galectin Therapeutics NASDAQ:GALT 3
Slide 4: What We Do
What We Do • Clinical stage biopharmaceutical company targeting fibrotic diseases and cancer with novel compounds that inhibit galectin proteins (galectin-3) • Galectin proteins are important in the development and promotion of many inflammatory, fibrotic and neoplastic diseases • Currently in clini
Slide 5: Key Facts – As of February 7, 2014
Key Facts – As of February 7, 2014 Trading Symbol Nasdaq: GALT Corporate Headquarters Norcross, GA (suburb of Atlanta) Stock Price; 52 Week Range $13.91 $2.61 -$17.88 Shares Outstanding 21.5 million Daily Volume (50 day average) 555,231 shares Market Capitalization $299 million Debt $0 Cash & Equiva
Slide 6: Experienced Leadership Team
Experienced Leadership Team © 2014 Galectin Therapeutics NASDAQ:GALT 6
Slide 7: Agenda
Agenda • The Company and Key Team Members • Galectin Inhibitors • Fibrosis Program – our key focus • Cancer Immunotherapy • Summary © 2014 Galectin Therapeutics NASDAQ:GALT 7
Slide 8: Galectin Proteins: Bind galactose residues on glycoproteins
Galectin Proteins: Bind galactose residues on glycoproteins • Galectin-3 is most important in pathological situations, is widely expressed, but highest in immune cells (macrophages) • Under normal physiological situations, galectin-3 is expressed at low levels • In areas of acute or chronic inflamma
Slide 9: Our drugs are natural complex carbohydrates that bind to galectin-3
Our drugs are natural complex carbohydrates that bind to galectin-3 and block interactions with natural ligands GR-MD-02 GM-CT-01 (simplified schematic) (simplified schematic) • Produced from • Produced from guar apple pectin gum • Method of use • Method of use patents in liver patents in liver fibr
Slide 10: Agenda
Agenda • The Company and Key Team Members • Galectins and Disease • Fibrosis Program – our key focus • Cancer Immunotherapy • Summary © 2014 Galectin Therapeutics NASDAQ:GALT 10
Slide 11: Fundamental Science on Target is Strong: Galectin-3 in organ fibrosis
Fundamental Science on Target is Strong: Galectin-3 is critically important in the development of organ fibrosis • Galectin-3 null mice (no galectin-3) are resistant to fibrosis due to toxin-induced liver toxicity Mice treated with liver toxin to induce fibrosis Red stain is collagen, Normal mouse N
Slide 12: Company’s Galectin Inhibitors Reverse Cirrhosis in Rat Model
Company’s Galectin Inhibitors Reverse Cirrhosis in Rat Model Vehicle Broad bands of • Animal model presented a very collagen with nodule high hurdle for drug treatment: formation (N) Cirrhosis induced with high dose indicates advanced toxin and continued throughout drug fibrosis and cirrhosis treatm
Slide 13: GR-MD-02 Improved Fat, Cell Death, Inflammation, Fibrosis in NASH Mouse Model
Galectin Inhibitor GR-MD-02 Improved Fat, Liver Cell Death, Inflammation, and Fibrosis in Mouse Model of Fatty Liver Disease (NASH) with Fibrosis Control Control Fat Red = Cell death Collagen Inflammation GR-MD-02 GR-MD-02 Fat Red = Cell death Inflammation Collagen © 2014 Galectin Therapeutics NASDA
Slide 14: Potential Use in Lung Fibrosis: GR-MD-02 Reduces Fibrosis in Mouse Model
Potential Use in Lung Fibrosis: GR-MD-02 Reduces Fibrosis in Mouse Model Normal Lung fibrosis induced by tracheal instillation of bleomycin followed by four infusions of either vehicle or GR-MD-02 Vehicle Large areas of confluent fibrosis. GR-MD-02 Marked reduction in area and severity of fibrosis w
Slide 15: Potential Use in Kidney Fibrosis: GR-MD-02 Reduces Fibrosis in Diabetic Mouse
Potential Use in Kidney Fibrosis: GR-MD-02 Reduces Fibrosis in Diabetic Mouse Normal Vehicle Arrows show areas of interstitial fibrosis GR-MD-02 Reduction in interstitial fibrosis © 2014 Galectin Therapeutics 15 NASDAQ:GALT
Slide 16: Liver Fibrosis Development Program
Liver Fibrosis Development Program NASH (Non-Alcoholic SteatoHepatitis): Very Large Unmet Medical Need • Multiple liver diseases lead to fibrosis which leads to liver failure, medical complications, and death • There is no approved medical therapy for liver fibrosis • Only current therapy is liver t
Slide 17: Development Program: Targeting Therapy In The Progression of NASH
Development Program: Targeting Therapy In The Progression of NASH Decades Obesity/Insulin Resistance/Diabetes Steatosis (fatty liver) NASH (inflammation, cell death) Clinical Outcomes Stage 1 2 3 Stage 4 Complications Fibrosis Cirrhosis Transplant Death Early Disease Late Disease • No certainty of p
Slide 18: Phase 1 Clinical Trial of GR-MD-02 in NASH with Advanced Fibrosis
Phase 1 Clinical Trial of GR-MD-02 in NASH (Fatty Liver Disease) with Advanced Fibrosis Patient inclusion: Biopsy proven NASH with advanced fibrosis (stage 3) Design: Each cohort has 8 patients (6 active, 2 placebo, blinded) Dose: Starting dose of 2 mg/kg which is within the presumptive therapeutic
Slide 19: Key Biomarkers for Assessing Potential Efficacy in Phase 1 Clinical Trial
Key Biomarkers for Assessing Potential Efficacy in Phase 1 Clinical Trial • Most important biomarkers are clinically validated composite scores that have been shown to correlate with fibrosis • ELF (Enhanced Liver Fibrosis) Score: Includes measurement of hyaluronic acid, tissue inhibitor of metallop
Slide 20: Phase 2 Clinical Trial Plans
Phase 2 Clinical Trial Plans • Patient inclusion: Biopsy proven NASH with advanced fibrosis (stage 3 and stage 4 with no complications of cirrhosis) • Design: Randomized, placebo controlled, and double blind. • Dose: Likely two dosage groups • Treatment Duration: TBD • Primary endpoint: Liver biopsy
Slide 21: Comparison of Galectin-3 Inhibitors
Comparison of Galectin-3 Inhibitors Galectin Thera. La Jolla Pharm. Galecto Biotech Drug GR-MD-02 GCS-100 TD 139 Drug Mod. apple pectin: Mod. citrus pectin; Modified lactose, a Characteristics MW: 20-70K; MWt >100K disaccharide aqueous solution* colloidal solution** Cell culture effects No cytotoxic
Slide 22: Competition in NASH
Competition in NASH NASH (inflammation, cell death) Clinical Outcomes Stage 1 2 3 Stage 4 Complications Fibrosis Cirrhosis Transplant Death Early Disease Late Disease • Focus is on improving • Focus is on stopping NAFLD Activity Score (8 progression or reversing points total): fibrosis • Fat (3 pts.
Slide 23: Fibrosis Strategy Summary
Fibrosis Strategy Summary • NASH with Advanced Fibrosis: Evidence of efficacy of GR-MD-02 from well controlled phase 2 clinical trial • Other Organ Fibrosis: Potential for partnering opportunities • Lung fibrosis – pre-clinical results suggest possible use in Idiopathic Pulmonary Fibrosis • Kidney f
Slide 24: Agenda
Agenda • The Company and Key Team Members • Galectin Inhibitors • Fibrosis Program – our key focus • Cancer Immunotherapy • Summary © 2014 Galectin Therapeutics 24 NASDAQ:GALT
Slide 25: Cancers Secrete Large Amounts of Galectins With Multiple Roles in Tumor Pathogenesis
The Vast Majority of Cancers Secrete Large Amounts of Galectins Which Have Multiple Roles in Tumor Pathogenesis • Tumor cell invasion: extracellular matrix adhesion & detachment • Metastasis: cell invasion and migration • Angiogenesis • Tumor immunity has recently been shown to be critically affecte
Slide 26: Checkpoint Inhibitor Blockade
May 22, 2013 Checkpoint Inhibitor Blockade • Marketed: • CTLA4 receptor mAb: Yervoy® (Ipilimumab, BMS) • In Development: • Anti-PD-1 (nivolumab BMS; lambrolizumab Merck) • Anti PD-L1 (MPDL3280A , Roche) Cancer Immunotherapy Named Top Scientific Breakthrough of 2013 by Science Magazine © 2014 Galecti
Slide 27: Cancer Therapy Strategy
Cancer Therapy Strategy • Focus on cancer immunotherapy based on the hypothesis that galectin inhibitors will enhance efficacy of immunotherapies • Metastatic melanoma is initial cancer indication • In US 76,000 new diagnoses and 9,100 deaths annually • 5% five year survival for metastatic disease •
Slide 28: Potential sites of action for galectin inhibition in tumor immunology
Potential sites of action for galectin inhibition in tumor immunology CD8+ Immunotherapies T-Cells Checkpoint Inhibitor Blockage: anti-CTLA4 anti-PD1 Galectin-3 Tumor Tumor Vaccines Clonal Cells Galectin-3 Expansion CD8+ T-Cells T-Cells Cytokines (kill tumor cells) Potential for galectin Potential f
Slide 29: Checkpoint inhibitors plus GR-MD-02 boosts anti-tumor immunity in mouse model
Checkpoint inhibitors plus GR-MD-02 boosts anti- tumor immunity, reduce tumor size and increase survival in mouse model of prostate cancer (similar results in breast cancer, melanoma and sarcoma) *p<0.05 aCTLA-4 = anti-CTLA-4 mAb [ipilimumab in humans (Yervoy, BMS)] aPD-1 = anti-PD-1 mAb [positive r
Slide 30: Phase 1B Clinical Trial in advanced melanoma with GR-MD-02 and Yervoy
Phase 1B Clinical Trial in patients with advanced melanoma using GR-MD-02 in combination with Yervoy® (ipilimumab): March 2014 Start Patient inclusion: Advanced melanoma with indication for Yervoy Rx Design: 3+3 dose escalation; 10 patients treated with MTD Dose: Starting dose of 1 mg/kg Infusion: G
Slide 31: Cancer Therapy Strategy: Summary
Cancer Therapy Strategy: Summary • Two immunotherapy agents have been approved for use to date, with many more vaccines and activators in development • Our strategy is to leverage world class expertise in basic tumor immunology and in the conduct of melanoma clinical trials. • Providence Portland Me
Slide 32: Agenda
Agenda • The Company and Key Team Members • Galectins and Disease • Fibrosis Program – our key focus • Cancer Immunotherapy • Summary © 2014 Galectin Therapeutics 32 NASDAQ:GALT
Slide 33: Summary of Development Program
Summary of Development Program • Liver Fibrosis • First indication: GR-MD-02 in NASH with advanced fibrosis • Phase 1 clinical trial underway; interim data expected March-April 2014 • Other Organ Fibrosis: Studies to demonstrate broad application of drugs in organ fibrosis; seek partner • Cancer The
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